Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial

July 11, 2026 updated by: Alexandre Chan, University of California, Irvine

Repurposing Riluzole for Augmenting Brain-Derived Neuropathic Factor (BDNF) Levels and Cognitive Function in Patients Experiencing Cancer-Related Cognitive Impairment: An Interventional Pilot Clinical Trial

This is a phase 2a, randomized, double-blinded, placebo-controlled pilot clinical trial determining the impact of riluzole therapy on circulating brain derived neuropathic factor (BDNF) levels in cancer survivors (recently completing prior treatment regimens) or patients who have received whole brain radiation for benign or malignant tumors with cancer related cognitive impairment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chao Family Comprehensive Cancer Center University of California, Irvine
  • Phone Number: 1-877-827-8839
  • Email: ucstudy@uci.edu

Study Contact Backup

  • Name: University of California Irvine Medical

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Chao Family Comprehensive Cancer Center, University of California Irvine
        • Contact:
          • Alexandre Chan, PharmD, MPH
          • Phone Number: 877-827-8839
          • Email: ucstudy@uci.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Cohort-specific inclusion for male and female patients.

    a. Cohort A (no prior cranial radiation) i. Diagnosed with one of the following:

    • Breast cancer exposed to treatment including chemotherapy, radiotherapy, surgery and/or other breast cancer interventions.
    • Non-breast cancer patients exposed to anthracyclines- or platinum-containing chemotherapy within the past 3 years.

    • Non-breast cancer patients exposed to other anticancer therapies within the past 3 years.

      b. Cohort B (prior cranial radiation)

    • Previously received radiotherapy or radiosurgery to the brain for benign, malignant, or metastatic tumors.
    • Life expectancy > 6 months
  2. Washout from investigational and conventional interventions is up to the discretion of the investigator. Concurrent participation in another intervention is allowable if judged by the Principal Investigator that this would not be scientifically or medically incompatible with this study.
  3. ≥18 years of age
  4. Perceived by patient or investigator that cognitive function has worsened since receipt of cranial radiation or cancer treatment.
  5. Able to provide informed consent.
  6. Literacy in English, Chinese, Korean, Vietnamese, or Spanish, to complete the questionnaires.

  7. Patients must agree to complete and be able to complete the questionnaires and computerized assessments used to measure functional outcomes.

    • Note: Patients who have visual impairment or have degenerative conditions (e.g. Parkinsons's disease, etc.) can participate if they cannot complete computerized assessments, as long as they can still complete the questionnaires with assistance.

Exclusion Criteria:

  1. Cohort-specific exclusion for male and female patients:

    1. Cohort A (no prior cranial radiation)

      • History of or current presence of primary brain tumors or brain metastases.

    2. Cohort B (prior cranial radiation)

      • Diagnosed with high grade glioma.
  2. Unwilling to undergo neuropsychological assessments necessary for the study.

  3. Women who are breastfeeding, pregnant or are planning to get pregnant during the study period. Persons of child-bearing potential (POCBP) must have a negative pregnancy test at screening if there is suspicion of pregnancy.

    a. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.

  4. History of suspected hypersensitivity to riluzole or to any of its excipients.
  5. Patients taking or planned to take medications/substances with potential drug-drug interactions: pixantrone, current smoker (defined as having smoked within the last month), abametapir, cannabis, capmatinib, lapatinib, methotrexate, and levoketoconazole.
  6. Hepatic impairment as indicated by: AST or ALT ≥ 3x upper limit normal (ULN)
  7. Have serious pre-existing medical conditions that, in the judgment of the investigator, would preclude participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Riluzole
Study participants randomized to this arm will take 50 mg of riluzole twice daily (every 12 hours) for 8 weeks
Drug: Riluzole
Given PO
Other Names:
  • RILUTEK
Placebo Comparator: Placebo
Study participants randomized to this arm will take a placebo, that matches the appearance of 50 mg capsule of riluzole, twice daily (every 12 hours) for 8 weeks
Drug: Placebo
Given PO

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in circulating Brain-Derived Neurotrophic Factor (BDNF) levels over time in cancer survivors experiencing cognitive impairment (CRCI)
Time Frame: 8 weeks
Comparing mean plasma BDNF values at each patient visit point, including before the intervention, at the midpoint, and at the endpoint of the study.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive Function Scores (FACT-Cog)
Time Frame: 8 weeks
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) scores, including both cumulative and perceived cognitive impairment scores. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes.There are four other scoring subscales in FACT-Cog v3: perceived cognitive impairments (PCI; 18 items); perceived cognitive abilities (7 items); impact of perceived cognitive impairment on QOL (4 items); and comments from others on cognitive function (4 items). Both total and PCI scores will be calculated in this study. Total score is calculated by summing scores from all the items and ranges from 0-148, and higher scores represent better subjective cognitive functioning. Similarly, PCI score is calculated by summing responses of all relevant items and ranges from 0 to 72.
8 weeks
Cognitive Function Scores (CANTAB)
Time Frame: 8 weeks
The study will assess the effects of riluzole on cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB) scores across five cognitive domains. These scores will be compared between intervention and placebo groups over time, with mixed effects models used to evaluate changes. Cognitive domains of response speed, learning and memory, working memory, multitasking, and sustained attention will be assessed with CANTAB®. Using International Cognition and Cancer Task Force (ICCTF criteria), overall cognitive impairment is defined as ≥ 2 standard deviations below normative mean on at least 1 cognitive test or ≥ 1.5 standard deviations below normative mean on 2 or more tests.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Irvine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alexandre Chan, PharmD, MPH, Chao Family Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4994
  • UCI 24-05 (Other Identifier: UCI CFCCC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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